Description and Brand Names

US Brand Name

Risperdal Consta

Descriptions

Risperidone injection is used to treat the symptoms of psychotic (mental) disorders, such as schizophrenia. It may be used alone or together with other medicines (e.g., lithium or valproate) to treat patients with bipolar disorder. This medicine should not be used to treat behavioral problems in older adults who have dementia.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Powder for Suspension, Extended Release

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of risperidone injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Elderly patients may be especially sensitive to the effects of risperidone. This may increase the chance of having side effects during treatment. This medicine should not be used for behavioral problems in older adults with dementia.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of risperidone injection in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution and an adjustment in the dose for patients receiving risperidone injection.

Pregnancy

Information about this risperidone-intramuscular-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amifampridine

Bepridil

Cisapride

Levomethadyl

Mesoridazine

Metoclopramide

Pimozide

Piperaquine

Terfenadine

Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide

Ajmaline

Amiodarone

Amisulpride

Amitriptyline

Anagrelide

Aprindine

Aripiprazole

Arsenic Trioxide

Asenapine

Astemizole

Azimilide

Bretylium

Bupropion

Buserelin

Chloral Hydrate

Chloroquine

Chlorpromazine

Citalopram

Clarithromycin

Crizotinib

Dabrafenib

Delamanid

Desipramine

Deslorelin

Dibenzepin

Disopyramide

Dofetilide

Dolasetron

Domperidone

Doxepin

Droperidol

Encainide

Enflurane

Erythromycin

Escitalopram

Flecainide

Fluconazole

Fluoxetine

Foscarnet

Gemifloxacin

Ginkgo Biloba

Gonadorelin

Goserelin

Halofantrine

Haloperidol

Histrelin

Hydromorphone

Hydroquinidine

Ibutilide

Imipramine

Ivabradine

Ketoconazole

Leuprolide

Linezolid

Lithium

Lorcainide

Mefloquine

Metronidazole

Milnacipran

Moxifloxacin

Nafarelin

Nortriptyline

Octreotide

Ondansetron

Pasireotide

Pazopanib

Pentamidine

Probucol

Procainamide

Prochlorperazine

Propafenone

Protriptyline

Quetiapine

Sematilide

Sertindole

Sertraline

Sevoflurane

Simvastatin

Sotalol

Spiramycin

Sulfamethoxazole

Sultopride

Tedisamil

Telithromycin

Tetrabenazine

Tramadol

Trifluoperazine

Trimethoprim

Trimipramine

Triptorelin

Vandetanib

Vemurafenib

Vinflunine

Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Carbamazepine

Cimetidine

Fosphenytoin

Itraconazole

Lamotrigine

Midodrine

Paroxetine

Phenobarbital

Phenytoin

Ranitidine

Ritonavir

Valproic Acid

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Alzheimer's disease or

Dehydration or

Heart attack, recent or history of or

Heart or blood vessel disease or

Heart failure, history of or

Heart rhythm problem, or a history of or

Hypotension (low blood pressure) or

Hypovolemia (low amount of blood) or

Stroke, history of or

Trouble with swallowing—May cause side effects to become worse.

Blood or bone marrow problems or

Bone problems (e.g., osteodystrophy) or

Breast cancer, prolactin-dependent or

Diabetes or

Hyperglycemia (high blood sugar) or

Hyperprolactinemia (high prolactin in the blood) or

Neuroleptic malignant syndrome (NMS), history of or

Parkinson's disease or

Priapism (painful or prolonged erection of the penis) or

Seizures, history of—Use with caution. May make these conditions worse.

Kidney disease or

Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into one of your muscles.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Risperidone injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause drowsiness, trouble with thinking, or trouble with controlling body movements. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

This medicine may make it more difficult for your body to cool itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke. Also, use extra care not to become too cold while you are taking risperidone injection. If you become too cold, you may feel drowsy, confused, or clumsy.

Risperidone injection may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicines including other narcotics; medicine for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

This medicine may increase prolactin blood levels if used for a long time. Check with your doctor if you have breast swelling or soreness; unusual breast milk production; absent, missed, or irregular menstrual periods; stopping of menstrual bleeding; loss in sexual ability, desire, drive, or performance; decreased interest in sexual intercourse; or an inability to have or keep an erection.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Aggressive behavior

agitation

anxiety

changes in vision, including blurred vision

difficulty concentrating

difficulty speaking or swallowing

inability to move the eyes

increase in amount of urine

loss of balance control

mask-like face

memory problems

muscle spasms of the face, neck, and back

problems with urination

restlessness or need to keep moving (severe)

shuffling walk

skin rash or itching

stiffness or weakness of the arms or legs

tic-like or twitching movements

trembling and shaking of the fingers and hands

trouble sleeping

twisting body movements

Less common

Back pain

chest pain

speech or vision problems

sudden weakness or numbness in the face, arms, or legs

Rare

Confusion

dizziness

drowsiness

extreme thirst

fast, shallow breathing

fast, weak heartbeat

headache

increased thirst

lip smacking or puckering

loss of appetite

muscle cramps

pale, clammy skin

poor coordination

prolonged, painful, inappropriate erection of the penis

puffing of the cheeks

rapid or worm-like movements of the tongue

shivering

talking, feeling, and acting with excitement and activity that cannot be controlled

uncontrolled chewing movements

uncontrolled twisting movements of neck, trunk, arms, or legs

unusual bleeding or bruising

unusual facial expressions or body positions

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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